Passive immunotherapy has been used since the late 19th century and in 1901, the first Nobel Prize in Physiology or Medicine was awarded for serum therapy for patients with diphtheria. During the 1918 epidemic, the serum of influenza patients was used to treat influenza, with some apparent success.1 Today, the use of immunoglobulin is established for the prophylaxis and treatment of a wide variety of infections, including respiratory infection viruses, cytomegalovirus, and people with hepatitis B or hepatitis A virus. Recently, passive immunotherapy has been evaluated for severe acute respiratory syndrome (SARS), Middle East respiratory syndrome and Ebola virus disease. Intravenous human immunoglobulin has revolutionized the management of immunoglobulin deficient states.
Convulsive plasma against SARS coronovirus 2 (SARS-CoV-2) is used for the treatment of patients with coronovirus disease 2019 (Kovid-19). Experience with influenza A is relevant, and a meta-analysis suggested that early treatment before significant disease develops may be an important predictor of the effectiveness of passive immunotherapy for that pathogen.1 The authors of that meta-analysis acknowledged the low quality of available evidence about early treatment. Another meta-analysis of studies of twisted plasma and hyperimmune immunoglobulin in patients with influenza A and SARS suggested a mortality benefit “when the convulsant plasma is administered after symptom onset.”2 However, in a randomized, controlled trial, high-titer coagulant plasma from patients recovering from H1N1 influenza was ineffective against severe influenza, an infection in hospitalized children and adults.3
An initial plasma randomized trial in patients with Kovid-19 focused on hospitalized patients who were already critically ill, and these trials provided weak evidence of clinical efficacy.4-6 Some were underestimated when nonpharmaceutical interventions such as masking and social and physical disturbances reduced the incidence of Kovid-19 and limited enrollment. Furthermore, these tests were heterogeneous with respect to the characteristics of the convulsive plasma used (for example, its antibody content and recipients’ stratification according to their serologic status). No unexpected safety signs have emerged beyond the recognized risks of plasma transfusion (ie, fluid overload, transfusion-associated acute lung injury, and allergy), nor is there evidence for antibody-dependent increase of the severity of Kovid-19. Accordingly, actionable conclusions about the diagnostic value of convulsive plasma are difficult to draw.
Observational studies have been more positive than randomized trials; Some, but not all, of these studies have modest clinical effects and measurable surrogate virologic results.7,8 They have confirmed the safety profile of plasma transfusion, but apart from potential biases and shortcomings inherent in observational studies, there are some issues similar to randomized trials.
The Food and Drug Administration (FDA) argued that the “totality of the evidence” suggested that the benefits of convulsive plasma would overcome its risks, and that given the lack of effective treatment, the FDA granted an Emergency Use Authority (EUA) Done and provided guidance. On the manufacture and use of spasm plasma in hospitalized patients with signs of progressive infection. In contrast, the National Institutes of Health’s guidelines panel stated that “data are inadequate to use or recommend against” the Infectious Diseases Society of America and AABB (formerly known as the American Association of Blood Banks )) States that the use of convulsive plasma is limited to clinical trials, which are unlikely to occur in critically ill patients and intensive care units (ICUs). In order to get the best results, the benefit of the plasma of infection should be used, and that the transfusion plasma should be used as quickly as possible during infection (possibly within 3 days after diagnosis).4
Given the number of SARS-CoV-2 infections, the lack of treatment options and the controversy and controversy about convulsive plasma, a high-quality, multilevel, randomized, controlled trial is most welcome. Libster and colleagues now report magazine10 Results of a well-performed test of early occlusive plasma in older adult patients in whom symptomatic SARS-CoV-2 infection was diagnosed with the use of a polymerase-chain-reaction assay. In this double-blind trial, a 250 ml complex plasma with a 1: 1000 IgG titer against the SARG-CoV-2 spike (S) protein was compared with saline placebo in patients aged 65 to 74 years Was and was investigated in coexisting conditions and patients who were 75 years or older with or without coexisting conditions.
Patients received convocation plasma or placebo less than 72 hours after symptom onset. In the intention-to-treat population, a primary end-point event (predetermined severe disease progression during follow-up) corresponds well to 16% (13 of 80 patients) and 31% (25 of 80 patients) Plasma and placebo groups respectively. A dose-dependent effect relative to antibody titers after infusion, and this effect was larger after the exclusion of 6 patients who had a primary end-point event before infusion. The benefits of convulsive plasma with respect to secondary end points were consistent with those associated with primary end points. No serious adverse events were observed. The authors conclude that “early administration of high-titer occlusive plasma against SARS-COV-2 reduces the progression of Kovid-19 to mildly infected older adults.” Even before the current trial, the EUA emphasized the potential benefits of early therapy with plasma of high-titer scales. Unfortunately, direct comparisons of antibody levels are not available in the current trial with the assays specified in the FDA EUA. Antibody titers were not provided in recipients at enrollment, so no comment can be made about the usefulness of prolific in patients as a criterion for convulsive plasma use.
At this time, convulsive plasma should be reserved for patients in whom the duration, severity, and risk of disease progression are similar to the patients in this trial. Small high-risk patients (and some immunological patients) with these disease characteristics should also be considered.
Convulsive plasma supplies have been difficult during the decline in the United States, with a significant increase in Kovid-19 cases, although recent collections have improved. From September 28, 2020 to September 27, the distribution of new and stored units of convulsive plasma to hospitals in the United States exceeded collections by 7785 units (Block W: personal communication). If collection is restricted to high-antibody titers and patient indications described in the article by Liebster et al., The supply of convulsive plasma will be emphasized. At my center, high-titer collections (as defined by the FDA) account for only 19.5% of seroactive concurrent plasma plasma donation. Moving the pool of potential recipients away from those in the European Union for a number of infected patients whose hospitalization and eventual need for advanced care cannot be precisely estimated is the convoluted plasma for the prehospital venus. May lead to expansion of transfusion (although this is not yet permitted in the EUA).
Uncontrolled compassionate use of convulsive plasma should be discouraged in patients other than an initial infection who are likely to aggravate a more serious disease, even if physicians recognize that a patient’s bed is ” How difficult it can be to just stand there “. ICU. Obstacles on treatments for Kovid-19 that are effective for limited patient populations are a powerful rationale for continued coherent adherence to non-pharmacological interventions and rapid deployment and acceleration of recommended vaccines.
Herbert Needleman, MD, a physician-scientist whose lead in consumer products was removed due to research…
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